(29 days)
BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2ª or ONE-STEP", or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.
BISFIL 2B (directed shrinkage composite) is a self-cure, base increment, radiopaque composite recommended for the "directed shrinkage" posterior composite technique suggested by Dr. Raymond Bertolotti. BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap. BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P". BISFIL 2B is intended to be used with ALL-BOND 2% or ONE-STEP", or similar universal dental adhesive system.
This looks like a 510(k) summary for a dental composite material, not a medical device involving AI or complex performance criteria that would require the detailed study information requested. The document describes a traditional dental material (BISFIL™ 2B) and compares it to a predicate device (BISFIL™ II) based on chemical composition and mechanical properties, not diagnostic accuracy or AI performance.
Therefore, many of the requested fields are not applicable to the provided text. I will fill in the relevant available information and indicate where information is not present or not applicable.
Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for the requested format:
Acceptance Criteria and Device Performance Study (BISFIL™ 2B)
This submission describes a dental composite material, BISFIL™ 2B, intended for use as a base increment in posterior restorations. The document focuses on demonstrating substantial equivalence to a predicate device (BISFIL™ II) based on chemical composition, intended use, and general mechanical properties, rather than complex performance metrics typically associated with AI-driven medical devices or diagnostic tools.
As such, many of the typical acceptance criteria and study components requested for AI or diagnostic devices are not applicable or not detailed in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (dental composite) and the provided document, specific numerical "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity) are not present. Instead, the document discusses concepts significant performance characteristics related to polymerization shrinkage and mechanical properties, and states that BISFIL™ 2B has similar properties to the predicate.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Polymerization Shrinkage Management | Should reduce or overcome effects of polymerization shrinkage, especially leading to directed shrinkage towards the tooth surface, to prevent marginal gaps and stress. | BISFIL™ 2B overcomes problems due to higher resin content and ability to flow in paste/fluid state during early curing. Hypothesis of directed shrinkage towards warmer tooth surface is plausible (supported by Garberoglio et al.). |
| Chemical Composition | Nearly identical to predicate device (BISFIL™ II). | Silica and glass filled dimethacrylate composite. Resin compositions nearly identical to BISFIL™ II. |
| Filler Content / Viscosity | Similar to predicate, potentially with minor adjustments for intended flow. | BISFIL™ 2B has somewhat less filler and lower viscosity than BISFIL™ II. |
| Mechanical Properties | Appropriate for dental restoration, analogous to predicate. | Non-clinical tests similar to ISO 4049 and ADA #27. Diametral tensile testing and flexural modulus are important for characterizing strength. Explicit results or direct comparison to predicate values are not provided in this summary. |
| Radiopacity | Radiopaque (implied for composite use). | Explicitly stated as "radiopaque composite." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary. The document mentions "non-clinical tests" but does not detail the number of samples used for these tests (e.g., number of test specimens for diametral tensile strength or flexural modulus).
- Data Provenance: Not specified. These would be lab-based mechanical and chemical tests, presumably conducted in-house or by a contract lab by BISCO, INC., in Itasca, IL, USA. The document does not refer to patient data or country of origin for such data.
- Retrospective/Prospective: Not applicable. These are material characteristic tests, not clinical studies in the traditional sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. For material characteristic tests, "ground truth" is established by laboratory measurement protocols and standards (e.g., ISO 4049, ADA #27).
- Qualifications of Experts: The document references "leading clinicians (Dr. John Kanca, Middlebury, CT)" for predicate device recommendations and "Dr. Raymond Bertolotti" for originating the "directed shrinkage technique" hypothesis. These individuals are clinical experts whose concepts are discussed, but they are not described as establishing "ground truth" for specific test sets in the manner of diagnostic image interpretation. James L. Sandrik, PhD, appears to be the author or a key scientific figure from BISCO, INC. involved in the submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert interpretations (e.g., in medical image reading). Material property testing relies on standardized measurement methods rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is a material science submission, not a diagnostic or AI-assisted interpretation device. Therefore, no MRMC study was conducted or is applicable.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This product is a dental material, not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). For this submission, "ground truth" for performance characteristics would be established by:
- Standardized Laboratory Measurements: Adherence to established standards like ISO 4049 and ADA #27 for diametral tensile strength, flexural modulus, and chemical composition.
- Literature (Scientific Consensus/Hypothesis Plausibility): The document refers to scientific literature (e.g., Garberoglio) to support the plausibility of the "directed shrinkage" hypothesis.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a material, not a machine learning model; therefore, it does not have a "training set."
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. This device is a material, not a machine learning model; therefore, it does not have a "training set" or corresponding ground truth.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.